Quantitative Estimation of Residual Solvents in anti-diabetic tablets manufactured by Multinational and National companies
in Pakistan
-
1
University of the Punjab, Pakistan
Background
Residual solvents (RS) are used in pharmaceutical products manufacturing processes from synthesis of active pharmaceutical ingredients/ excipients to the final formulation. RS remain in the final products in the form of volatile impurities can be toxic to health.
Methods
An efficient and sensitive headspace gas chromatography (HS-GC) method was developed and validated for determination of twelve RS in thirteen coated anti-diabetes tablets. In order to increase the method sensitivity and efficiency, dimethyl sulfoxide was utilized as diluent owing to its high dissolving capacity for drug substance, stability and boiling point. Headspace auto-sampler was set to multiple extraction mode with 80°C, 90°C and 105°C as oven, loop and transfer line temperatures, respectively. Separation was achieved on HP- Innowax polyethylene glycol gas chromatographic column (30 m × 250 µm × 0.25 µm) using nitrogen as a carrier gas. GC inlet temperature was set at 140°C with split ratio 10:1 and 250°C flame ionization detector temperature.
Results
The method showed good linearity (r2≥ 0.9990) in the range of 50-1000 μg/mL with 5μg/mL as limit of detection. Accuracy and precision at three different concentrations was 90-113% and less than 15% respectively. All tested tablets contained methylene chloride, methanol, n-hexane, toluene and cyclohexane within permissible exposure limits. But in two products (15% of total products tested), the amount of RS were approaching upper limits.
Conclusion
Daily administration of tablets with high RS amount can lead to severe health hazards. It is strongly recommended to include RS analysis in regular pharmaceutical quality control testing protocols.
Acknowledgements
Authors would like to acknowledge University College of Pharmacy, University of the Punjab, Lahore, Pakistan for their kind support and encouragement
Keywords:
Headspace gas chromatography,
Residual solvent,
Anti-diabetes tablets,
multinational,
national
Conference:
International Conference on Drug Discovery and Translational Medicine 2018 (ICDDTM '18)
“Seizing Opportunities and Addressing Challenges of Precision Medicine”, Putrajaya, Malaysia, 3 Dec - 5 Feb, 2019.
Presentation Type:
Poster Presentation
Topic:
Miscellaneous
Citation:
Latif
A,
Anwar
R and
Raza
A
(2019). Quantitative Estimation of Residual Solvents in anti-diabetic tablets manufactured by Multinational and National companies
in Pakistan.
Front. Pharmacol.
Conference Abstract:
International Conference on Drug Discovery and Translational Medicine 2018 (ICDDTM '18)
“Seizing Opportunities and Addressing Challenges of Precision Medicine”.
doi: 10.3389/conf.fphar.2018.63.00007
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Received:
25 Sep 2018;
Published Online:
17 Jan 2019.
*
Correspondence:
Prof. Abida Latif, University of the Punjab, Lahore, Pakistan, abidalatif43@yahoo.com